Recall record at a glance
| Official record | Z-2355-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | In2bones USA, LLC |
| Report date | Jun 17, 2026 |
| Recall initiation date | May 11, 2026 |
| Quantity | 306 kits |
| Location | Cordova, TN, United States |
Official product description
NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
Why the product was recalled
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Distribution information
U.S.: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WI O.U.S.: Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, United Kingdom,
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: N/A.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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